Drug delivery systems with sealed and sterile fluid paths and methods of providing the same

Abstract

The present disclosure relates generally to the field of drug delivery. In particular, the present disclosure relates to a drug delivery system that includes a sealed and sterile fluid path attached to a drug-loaded container. The disclosure further relates to methods for sterilizing a portion of the drug delivery system without exposing the drug-loaded container to harmful sterilization parameters.

The invention claimed is: 
     
       1. A method, comprising:
 providing an energy source and a drug delivery system; and 
 positioning a shield between the energy source and the drug delivery system, the drug delivery system comprising a container, a fluid path, and a cover, wherein the container holds a liquid drug, wherein a first end of the fluid path is disposed within the container, and wherein a second end of the fluid path is disposed within the cover. 
 
     
     
       2. The method of  claim 1 , further comprising:
 emitting energy from the energy source; 
 sterilizing the fluid path by exposing the fluid path to the energy emitted by the energy source; and 
 blocking exposure of the liquid drug to a substantial portion of the energy emitted by the energy source. 
 
     
     
       3. The method of  claim 2 , further comprising sterilizing the liquid drug prior to sterilizing the fluid path. 
     
     
       4. The method of  claim 1 , wherein positioning the shield comprises positioning an aluminum shield having a thickness of at least 30 mm between the drug delivery system and the energy source. 
     
     
       5. The method of  claim 1 , further comprising piercing a cap sealing the container with the first end of the fluid path to couple the liquid drug to the fluid path. 
     
     
       6. The method of  claim 1 , further comprising piercing a septum sealing the container with the first end of the fluid path to couple the liquid drug to the fluid path. 
     
     
       7. The method of  claim 1 , further comprising piercing a plunger sealing the container with the first end of the fluid path to couple the liquid drug to the fluid path. 
     
     
       8. The method of  claim 1 , wherein positioning the shield comprises placing the fluid path and the container within a first shield component having an exposure window and coupling a second shield component to the first shield component. 
     
     
       9. A method for sterilizing a liquid drug in a drug delivery system, comprising:
 positioning a shield between an energy source and the drug delivery system, the drug delivery system comprising a fluid path and a container holding the liquid drug; and 
 exposing the fluid path to an energy emitted by the energy source, wherein the shield blocks exposure of the liquid drug to at least a portion of the energy. 
 
     
     
       10. The method of  claim 9 , further comprising sterilizing the liquid drug prior to sterilizing the fluid path. 
     
     
       11. The method of  claim 9 , wherein positioning the shield comprises positioning an aluminum shield having a thickness of at least 30 mm between the drug delivery system and the energy source. 
     
     
       12. The method of  claim 9 , further comprising piercing a cap sealing the container with the fluid path to couple the liquid drug to the fluid path upon activation by a user. 
     
     
       13. The method of  claim 9 , further comprising piercing a septum sealing the container with the fluid path to couple the liquid drug to the fluid path upon activation by a user. 
     
     
       14. The method of  claim 9 , further comprising piercing a plunger sealing the container with the fluid path to couple the liquid drug to the fluid path upon activation by a user. 
     
     
       15. The method of  claim 9 , wherein positioning the shield comprises placing the fluid path and the container within a first shield component having an exposure window and coupling a second shield component to the first shield component. 
     
     
       16. A method, comprising:
 positioning a shield between an energy source and a drug delivery system, the drug delivery system comprising a fluid path for accessing a liquid drug within a container; and 
 exposing the fluid path to an energy emitted by the energy source, wherein the shield blocks exposure of the liquid drug to at least a portion of the energy. 
 
     
     
       17. The method of  claim 16 , further comprising blocking exposure, by the energy emitted from the energy source, of an entire portion of the container and at least a portion of a cap inserted within the container. 
     
     
       18. The method of  claim 17 , further comprising piercing the cap with the fluid path to couple the liquid drug to the fluid path upon activation by a user. 
     
     
       19. The method of  claim 16 , further comprising exposing an entire portion of the fluid path to the energy emitted by the energy source. 
     
     
       20. The method of  claim 16 , wherein positioning the shield comprises placing the fluid path and the container within a first shield component having an exposure window and coupling a second shield component to the first shield component.